Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 主要终点
- the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale
研究概览
简要总结
A surgical abortion under local anesthesia is potentially painful. A protocol using analgetic is systematically used. Also the protocol is relevant , the question of taking care of the pain in a safe manner remains.
The use of Music during surgery can have a real effect on pain and anxiety. This study has for goal to evalued the use of music on pain as adjuvant treatement instead of a standard care for an abortion.
详细描述
A surgical abortion under local anesthesiac is potentially painful. A protocol using analgetic is systematically used. Also the protocol is relevant, the question of taking care of the pain in a safe manner remains.
The use of Music during surgery can have a real effect on pain and anxiety. This study has for goal to evalued the use of music on pain as adjuvant treatment instead of a standard care for an abortion.
The number of patients needed is estimate to be eighty patients per group.
The result of the study could allow :
- Showing the effectiveness of music intervention before operative abortion as adjuvant treatment on the pain, anxiety and nausea during a surgical abortion by suction aspiration under local anesthesia.
- Improving the experience of an abortion and the satisfaction of the patients as well as lowering the use of drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Every patients must have more than 18 years old
- •Hospitalised at the Angers Hospital for a surgical abortion under local anesthesia.
- •Affiliated or be part of the french Sécurité Sociale ( health service )
- •To have signed a consent form
排除标准
- •Patients not speaking french
- •People who should not use music intervention ( Total or partial hearing difficulties)
- •No consent given
- •Adults protected by the law
- •Not being part of another medical study
研究组 & 干预措施
Controlled group
For the patients in the " controlled " group, the use of analgesic will be use if needed during the procedure
干预措施: Controlled group (Behavioral)
Music intervention group
For the patients in the Music intervention group, a adjuvant treament by a music intervention will be use before the procedure
干预措施: Music intervention group (Behavioral)
结局指标
主要结局
the effectiveness on the pain of music therapy by the pain evaluation with visual numeric scale
时间窗: during one day
evaluation is maide five times
次要结局
未报告次要终点